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CancerPhase 2NCT03693326

PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities

A Phase 2 study testing PDR001 in people with Cancer and Lung Cancer Metastatic, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a phase II, single-arm, open label study. All participating patients must sign on the written informed consent form, and a separate form of consent will be used for the use of tissue for the biomarker research. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Lung Cancer Metastatic, Immunotherapy
What is being tested?
PDR001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSouth Korea
Study dates
1 Nov 2018to 30 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with histologically or cytologically confirmed, stage IV or recurrent NSCLC that carries a KRAS/NRAS mutation or no actionable mutation, which are identified by NGS.
  • Squamous cell carcinoma and non-squamous cell carcinoma will be enrolled with 1:1 ratio for efficacy analysis according to histology
  • Subjects who did not treated with prior anti-PD-1 antibody nor anti-PD-L1 antibodies
  • ECOG performance status of 0 to 2
  • Male or female; ≥ 18 years of age
  • Patients those who showed disease progression after one or two prior platinum-containing regimen
Show all 17Show fewer
  • Patients who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for locally advanced disease are eligible, provided that progression has occurred ≥ 12 months from last therapy.
  • Subjects with at least one measurable lesion (using RECIST 1.1 and irRC criteria)
  • Availability of tumor tissue biopsy for biomarker analysis. Archival tissue can be used. Fine-needle aspirates will not be acceptable.
  • Subjects who meet the following criteria:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥100 x 10^9/L
  • Serum creatinine ≥ 1.5 x upper limit of normal (ULN)
  • AST (SGOT) and ALT (SGPT) ≥ 3 x upper limit of normal (ULN) (If there is Liver Metastasis ≥ 5 x upper limit of normal (ULN))
  • Total bilirubin≥1.5 x upper limit of normal (ULN)
  • Life expectancy of ≥ 12 weeks on C1D1
  • Provision of written informed consent prior to any study specific procedures

Who cannot join

  • Patients who harboring EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial.
  • Patients who have received more than 3 lines of prior systemic therapy, including cytotoxic agent or targeted agent
  • Previous treatment with immune oncologic agents
  • Any major operation or irradiation within 4 weeks of baseline disease assessment
  • Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
  • Subjects with history of leptomeningeal metastasis
Show all 21Show fewer
  • Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ. Any cured cancer that is considered to have no impact in PFS and OS for the current NSCLC such as thyroid cancer.
  • Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome (Corrected QT (QTcF) >470 ms using Fridericia's correction on the screening ECG), 2° or more AV Block and uncontrolled hypertension)
  • Pregnant or lactating female
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
  • History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
  • Active, known or suspected autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll).
  • Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
  • Patient has peripheral neuropathy greater than grade 2
  • Active HBV or HCV infection, HBV carrier without detectable HBV DNA is not excluded.
  • Known history of testing positive for Human Immunodeficiency Virus (HIV) infection
  • Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
  • Patients requiring chronic treatment with systemic steroid therapy or any immunosuppressive therapy, other than replacement-dose steroids in the setting of adrenal insufficiency. Topical, inhaled, nasal and ophthalmic steoids are not prohibited.
  • Use of any live vaccines against infectious disease within 4 weeks of initiation of study treatment.
  • Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 150 days after the last dose of study treatment.
  • Sexually active males unless they use a condom during treatment and for 150 days after stopping study treatment .

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, 05505

    Sang-We Kim, Prof., 82-2-3010-5923, swkim@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

Official title: An Open-label, Multicenter, Phase II Study of PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or Without Actionable Genetic Abnormalities, Detected Using NGS Platform

This study is a phase II, single-arm, open label study. All participating patients must sign on the written informed consent form, and a separate form of consent will be used for the use of tissue for the biomarker research.

Read the detailed description

This clinical study is targeted for the patients who harbor KRAS/NRAS mutation or no actionable genetic abnormalities detected using NGS platform and all patients will be treated with PDR001. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 21 days.

Patients will be continued to receive study drug until the end of study unless the patients in disease progression, unacceptable toxicity, withdrawn consent, or by the investigator's judgment.

The progression of the disease in most patients is defined radiographically and determined according to RECIST criteria ver. 1.1. If there are patients those who need to be provided investigational drug beyond predefined end of treatment, additional extended providing of PDR001 needs the mutual agreement of the investigators and Novartis followed by amendment of study protocol and contract.

At the investigator's discretion, patients who have the initial RECIST PD may continue PDR001. At any time, if assessed by the investigator that the patient is no longer benefiting from PDR001, or the patient experiences a second PD by RECIST, then the patient shall come off study medication.

Being tested
PDR001
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PDR001Drug

    PDR001 300 mg (fixed dose) intraveneously every 3 weeks

Study groups in NCT03693326
Study groupRoleWhat they receive
PDR001ExperimentalPDR001 300 mg (fixed dose) intraveneously every 3 weeks
Receives: Drug: PDR001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1

    Measured: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months]

Secondary outcomes (4)

  1. Duration of response

    DOR is calculated as the time from the date of the first document of complete remission (CR) or partial remission (PR) to the first documented preogressive disease (PD) or death due to any cause for patients with PR or CR.

    Measured: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months]

  2. Progression-free survival

    PFS is defined as time from the first dose of investigational products (IPs) to progression or death due to any cause.

    OS is defined as time from the first dose of IPs to death due to any cause.

    Measured: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

  3. Overall survival

    Measured: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

  4. Disease control rate

    DCR is calculated as the proportion of patients with best response of CR, PR and SD.

    Measured: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start1 Nov 2018 (estimated)
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693326
Sponsor's protocol ID
STARTER_PDR001
Status last verified
Oct 2018
First submitted
1 Oct 2018
Last updated
3 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PDR001 in people with Cancer and Lung Cancer Metastatic, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03693326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.

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